510(k) K072922 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
3S HEMI TOE
| Applicant | Trilliant Surgical, Ltd., Round Rock TX, US |
| Decision | Substantially Equivalent, Nov 28, 2007 |
| Received | Oct 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072922
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, H Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.